Apparatus and method for retraction of tissue

ABSTRACT

A self-retaining retractor and surgical method of retracting integument at a surgical site comprising a medial arm moveably connected to a first end of an extension arm. The extension arm is connected to a lateral arm. The connection may be made after the medial arm is in the surgical site. The extension arm may be moved from an undeployed position to a deployed position. The medial arm or the lateral arm may include a surgical instrument holder, such as a holder for an endoscope. A locking mechanism may be used to lock the retractor in a deployed position. A strap may also be used to secure the retractor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application contains subject matter that is common to, and is anon-provisional application of, co-pending U.S. Provisional PatentApplication Ser. No. 61/275,785, entitled “AN APPARATUS FOR RETRACTIONOF TISSUE FOR AND DURING SURGICAL PROCEDURES AND PROCESS FOR MAKINGSAME”, filed Sep. 2, 2009, which application is incorporated byreference herein in its entirety. This application claims priority under35 U.S.C. §119(e) as to common subject matter.

BACKGROUND OF THE INVENTION

1. Field of Invention

The present invention relates to surgical procedures and apparatus, andmore specifically to a self-retaining retractor and surgical method ofusing a self-retaining retractor at a surgical site.

2. Background of Invention

Surgical “retraction” is the drawing back of body tissue. When asurgical procedure involves making an incision, the incision site itselfoften must be retracted in order for the surgery to proceed throughcompletion. During surgery, internal organs, bones, and tissues areintermittently retracted through the opening created in the retractedincision site.

In certain surgeries, an assistant's fingers are used as retractorpaddles to hold the site of the incision open. However, greatertechnical ease is available through the use of various mechanicalretractor systems. Such mechanical retractor systems can be divided intotwo major groups: externally mounted “fixed” to the operating table andself-retaining retractors.

Mechanical systems attached to the operating table present the same typeof physical obstruction to the movements of the surgeon as presented bythe assistant's body, arms, and hands since the externally fixedretractor system consists of a vertical column, supporting ring or armsand retractor paddles attached thereto. All components of the fixedretractor system are adjustable in multiple planes and axes of motion.These components, however, are not independently adjustable in thevertical plane; movement of a ring or support arm of the fixed retractorsystem necessitates movement and adjustment of all retractor paddlesattached thereto.

Ideally, mechanical tissue retractors, both externally mounted and selfretaining, need to provide for internal organ, bone, and tissueretraction. Both types of retractor systems need to be quickly andeasily assembled, positioned, and repositioned in all planes and axes ofmotion, and present as little obstruction as possible to the surgeonsmovements and line of sight. Both types of retractor systems mustprotect the sterile field, diminish the risk of tissue trauma and stillremain sufficiently stable to function properly without the need forassistance.

Self-retaining retractors have attempted to provide for internal organand tissue retraction through the open incision, but have failed topermit quick, independent, easy and safe adjustment of internal organand tissue retractor arms in all planes and axes of motion. Furthermore,self-retaining retractors have failed to provide an internal supportmechanism for bone, organs, and tissue within the incision site, makingthe prior art ineffectual, unsafe, or both. Existing self-retainingretractors are not readily or easily adjustable in the vertical planeand must traverse through or over internal tissue before reaching theoptimal location for the surgical procedure.

Various patents have issued relating to surgical retractors. U.S. Pat.No. 5,520,610 issued to Giglio on May 28, 1996 describes aself-retaining retractor that includes flexible, resilient retractorpaddles which can be placed into the incision. A rigid frame includestwo interlocking halves that lay over the incision longitudinally. Theincision retractor paddles are manually clipped to each frame half andthe frame halves may then be opened to the extent of tissue retractiondesired.

U.S. Pat. No. 6,074,343 issued to Nathanson et al. on Jun. 13, 2000describes a surgical incision retractor to be used in small tissueincisions and includes a plurality of blades that can be operatedsimultaneously or at least one or more blades can be operatedindependently. Right and left retractor blades are mounted on anactuator mechanism that spreads or expands the blades as a rotatableprimary actuator knob is rotated. A third retractable arm is mounted forsimultaneous operation with the right and left retractor blade orindependent operation through a secondary rotatable actuator knob thatextends or retracts a threaded shaft attached to the center retractorblade.

U.S. Pat. No. 7,022,069 issued on Apr. 4, 2006 to Masson and Henrydescribes a circumferential retractor apparatus including a firstretractor paddle, a second retractor paddle and an elastic member. Eachof the first and second retractor paddles includes a body portion withan arm extending outwardly therefrom. The arm supports a graspingsurface. The arm of the retractor paddle has a hole formed thereinthrough which the elastic member passes.

On Jun. 25, 2002, Masson and Henry were granted U.S. Pat. No. 6,409,731describing a bone leveler or apparatus that includes a first blademember having a forward end suitable for contacting the bone and arearward end, a second blade member having a forward end suitable forcontacting the bone and a rearward end, and an elastic member having oneend received by the first blade member and an opposite end received by asecond blade member. Each of the blade members has an identicalconfiguration. Each of the blade members has a hole formed between theforward end and rearward end. The elastic member has one end received bythe hole of the first blade member and an opposite end received by thehole of the second blade member.

A typical procedure generally involves an operating team of trainedpractitioners that includes a surgeon and at least one assistant ormore, depending on the complexity of the operation. Once an operationsite is sterile, as recommended, and the operating team and patientprepped, a surgeon will usually make a predetermined incision ofintegument, such as skin, in order to view and access a predeterminedregion of the patient's body.

A tool typically used in the medical field to create and maintain anaperture is commonly referred to as a retractor. A basic retractorcomprises a blunt object—or other form object that will not perforate,deform, or compromise an incised edge—and is generally referred to as anpaddle or arm (as referenced herein). The arm may be similar in width tothe width of an incision and of a length sufficient to be insertedthrough an incision to a desired depth of a patient's body while capableof being manipulated from outside the patient's body. Force is usuallyapplied to a portion of an inserted arm, distal to incised edges, whichcauses integument to separate or retract, thus forming an aperture.

Depending on the degree of surgical procedure that is performed, anaperture may need to be maintained for a short period of time or forhours. It is not uncommon for a practitioner to use a finger as an armor other object to retract and retain integument. This practice requiresconstant manual/physical force and can be undesirable because the fingermay obstruct a surgeon's view, may fatigue, or may be distracted andmove which can result in injury to a practitioner or patient. Therefore,when manual retractors are avoided, practitioners may use mechanicalarms to separate integument and maintain an aperture.

Mechanical retractors generally involve connecting an arm to astationary object outside the incision, like an operating table, hanger,or frame supported by a patient. This type of retractor has been knownto cause obstruction to practitioners and even injury to a patient ifthey move during surgery or when a time consuming disassembly isrequired in an emergency situation.

SUMMARY OF THE INVENTION

The aforementioned shortcomings of retractors have been addressed by thepresent invention. In accordance with an aspect of the presentinvention, a self-retaining retractor and surgical method of retractingintegument at a surgical site is disclosed.

In an embodiment of the retractor of the present invention, a medial armis moveably connected to the first end of an extension arm. Both armsare substantially planar in a closed position to provide for minimalimpedance to integument when inserted into an incision. A lateral armconnects to the second end of the extension arm such that when force isapplied to the lateral arm in a general subdermal direction, theextension arm is driven out of plane with the medial arm. The lateralarm may then pivot about its axis with the extension arm away from themedial arm, thereby causing the incision to open and forming anaperture. Arms may thereafter be locked relative to each, in order toprovide a self-retained retraction of an incision site for the durationof a surgical procedure. Once the retractor is locked in place,practitioners' hands are free so that the surgeon may concentrate onusing them for the procedure, which may allow a procedure to beperformed using a smaller team, thereby minimizing the number ofsurgical tools required, reducing risks of injury to patients andpractitioners, reducing labor costs, and lowering the potential forinfections to the patient and violations of the sterile field bypractitioners.

In another embodiment of the invention, the dimensions of one arm may bethe same or different from dimensions of another arm, in order toaccommodate variable visualization and exposure requirements accordingto a procedure.

An object of the invention is to provide a self-retaining retractor andmethod of use for surgical procedures.

Another object of the invention is to provide a self-retaining retractorand method of use for superior visualization of an incision site withoutinterference from practitioner hands, which otherwise may obstruct apractitioner's view or block light.

It is another object of the invention to provide a self-retainingretractor and method of use for optimal visualization of an incisionsite without hands-on manipulation of a retractor.

It is a yet another object of the invention to provide a self-retainingretractor and method of use wherein any arm can be selectively attachedto a common extension arm and conjoined using a locking mechanism.

A still further object of the invention is to provide a self-retainingretractor and method of use that minimizes the number of practitioners.

Another object of the invention is to provide a self-retaining retractorand method of use which reduces fatigue and risk of injury topractitioners who might otherwise be directed to use conventionalretractors.

Another object of the invention is to provide a serf-retaining retractorthat includes a surgical instrument holder, such as an endoscope holder.

An object of the invention is to provide a self-retaining retractor andmethod of use for repair of tendons.

Another object of the invention is to provide a self-retaining retractorand method of use for posterior surgical reconstruction of the lateralknee.

A further object of the invention is to provide a self-retainingretractor and method of use for surgical repair of distal ulnarfractures.

Yet another object of the invention is to provide a self-retainingretractor and method of use for surgical repair of lateral malleolusfractures.

Still yet another object of the invention is to provide a self-retainingretractor and method of use for surgical repair of metatarsal fractures.

Another object of the invention is to provide a self-retaining retractorand method of use for surgical repair of metacarpal fractures.

Another object of the invention is to provide a self-retaining retractorand method of use for veterinary surgical procedures.

The above and other novel features of the present invention will becomeapparent to those of ordinary skill in the art upon further reviewingand understanding the following detailed description and accompanyingdrawings. It is intended that additional organizations, methods of useand operation, features, objects, embodiments, and or advantagesascertained by one skilled in the art be included within thespecification, the scope of the invention, and protected by the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may take form in various components and arrangements ofcomponents, and in various steps and arrangements of steps. The drawingsare only for purposes of illustrating embodiments and are not to beconstrued as limiting the invention.

FIG. 1 is a perspective view of an embodiment of the invention in use.

FIG. 2 is a perspective view of an embodiment of the invention in thedeployed position.

FIG. 3 is a front plan view of an embodiment of the invention in theundeployed position.

FIG. 4 is a front plan view of an embodiment of the invention in thedeployed position.

FIG. 5 is a partially exploded perspective view of an embodiment of theinvention in the deployed position.

FIG. 6 is a top view of an embodiment of the invention in the deployedposition.

FIG. 7 is a detail view of the connection of the medial arm and theextension arm and the locking mechanism of the invention in the deployedposition.

FIG. 8 is a front plan view of another embodiment of the invention inthe undeployed position.

FIG. 9 is a partially exploded perspective view of another embodiment ofthe invention in use in the undeployed position.

FIG. 10 is a detail view of the connection of the medial arm and theextension arm and the connection between the extension arm and thelateral arm of an embodiment of the invention.

FIG. 11 is a reverse detail view of the connection of the medial arm andthe extension arm and the connection between the extension arm and thelateral arm of an embodiment of the invention.

FIG. 12 is a perspective view of another embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIGS. 1-5, in accordance with an embodiment of theinvention, there is disclosed a medical device 10 for retraction oftissue for a surgical procedure, while in an open position or operativestate. As shown in FIG. 1-5, the device 10 comprises a medial arm 12having a first end 14 and a second end 16. The second end comprises acurved region 18. The curved region may be shaped like that of a Hohmannretractor, or other shape suitable for the purpose of the retraction. Inone embodiment, as shown in FIG. 1, the curved end 18 is capable ofbeing placed below a bone 20, such as the radius. Medial arm 12 isconnected to an extension arm 22 by a rotatable connection 24 such as ahinge joint. The rotatable connection 24 allows the extension arm 22 tobe selectively positioned about the axis of rotation. The rotatableconnection 24 may be a pivot or any removable or permanent, fixed orvariable connection means that provides for a rotatable axis betweenmedial arm 12 and extension arm 22 and allows for freedom of positioningof the extension arm 22 during deployment of the device 10 or during aprocedure.

As shown, in FIGS. 3-7, the rotatable connection 24 between the medialarm 12 and the extension arm 22 may include a locking mechanism 26. Inone embodiment, the locking mechanism 26 may include a gap 28 betweenprotrusions 30 on the rotatable connection 24 for inclusion of a lockingpin 32. The locking mechanism may also include a guide 34 for thelocking pin located on the medial arm 12. The guide 34 may be a hypotubeor the equivalent, and may be used to hold the locking pin 32. Thelocking pin may be a K-wire or the equivalent. Other locking mechanismsknown in the art are also contemplated.

The device 10 may also include at least one surgical instrument holder36 located on the medial arm 12. The surgical instrument holder 36 maybe bracket clamped to the medial arm receiving a locking pin, a taperedbracket, a clip, hook and loop fastener or an equivalent holder. Theholder 36 may be for an endoscope or other instrument needed forsurgery. The holder 36 may be selectively positioned longitudinally andlaterally about medial arm 12 and may also be capable of rotating orswiveling about medial arm 12 depending on the instrument to be held orneeds of a user. As shown, the holder 36 may be connected to medial arm12 by a clamping device. A plurality of holders 36 may be disposed onthe medial arm 12 or elsewhere on the device 10 and configured tosupport a plurality of instruments depending on the instruments beingheld or needs of a user.

The device 10 also includes a lateral arm 38 having a near end 40 and afar end 42 that may have a connection 44 with the extension arm 22. Asshown in FIGS. 1-4 and 8-9, the connection 44 between the lateral arm 38and the extension arm 22 may be removable so that the lateral arm 38 maybe attached to or removed from the extension arm 22 at the time of theuser's choosing. FIG. 8 illustrates the device 10 showing the extensionarm 22 in an undeployed position wherein the lateral arm 38 is removed.As shown in FIGS. 9-11, the connection 44 may comprise a pin-and-slotjoint. For example, the lateral arm 38 may have a pin 46 insertable intoa slot 48 located on a projection 50 on the extension arm 22. As shown,the slot 48 may be L-shaped. Alternatively, the connection 44 may be asnap-joint. Other equivalent means of making the connection are alsocontemplated.

In an alternative embodiment, as shown in FIG. 12, the far end 42 of thelateral arm 38 may further comprise a curved region 52. Like the curvedregion 18 of the medial arm 12, the curved region 52 of the lateral arm38 may be similar to the curved portion of a Hohmann retractor, or ofanother shape suitable for the needs of the user.

In another embodiment, the lateral arm includes a holder for a surgicalinstrument, such as an endoscope. The holder on the lateral arm may beas described for the embodiment having a holder on the medial arm.

In an alternative embodiment shown in FIGS. 1, 9 and 12, the first end14 of the medial arm 12 may include a first band connector 54 and thenear end 40 of the lateral arm 38 may include a second band connector56. As shown, the first band connector may be a slot adapted forreceiving a loop for a band or strap 58 and the second band adaptingreceiving the band or strap so that the strap is tightenable around theportion of the body that receives the incision and the retraction forthe procedure. As shown in FIG. 1, the strap may also be secured toitself by complementary hook 60 and loop 62 fastener regions. The strapmay alternatively be secured with a buckle or equivalent method. Othermeans for securing the device 10 and holding a band or strap are alsocontemplated. In addition, as shown in FIG. 12, the device 10 mayinclude a cuff 64 to aid in the isolation of the retracted area.

The method of the invention as used is described as follows. The deviceis introduced into an incision with the medial arm and the extension armin the undeployed position as shown in FIG. 3. Alternatively, the devicemay be introduced with the extension arm in the undeployed position withthe lateral arm detached from the extension arm as shown in FIG. 7. Thecurved portion of the device may then be placed under a bone accessiblethrough the incision. Then the lateral arm may be connected with theextension arm. The extension arm may then be extended into the deployedposition. The extension arm may then be locked by a locking mechanism.Then a band, strap or other tightening mechanism attached to the medialarm and the lateral arm may be tightened.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that the accompanying drawings are notto scale. A variety of modifications and variations are possible inlight of the above teachings without departing from the scope and spiritof the invention

1. A self-retaining retractor comprising: a medial arm having a firstend and a second end; a lateral arm having a first end and a second end;and an extension arm having a first end in rotatable connection with themedial arm and a second end in connection with the lateral arm towardthe second end of the lateral arm.
 2. The self-retaining retractor ofclaim 1 wherein the second end of the medial arm further comprises acurved region.
 3. The self-retaining retractor of claim 1 wherein thesecond end of the lateral arm further comprises a curved region.
 4. Theself-retaining retractor of claim 2 wherein the curved region comprisesa Hohmann retractor curve.
 5. The self-retaining retractor of claim 1wherein the medial arm further comprises a surgical instrument holder.6. The self-retaining retractor of claim 5 wherein the surgicalinstrument holder is an endoscope holder.
 7. The self-retainingretractor of claim 1 wherein the lateral arm further comprises asurgical instrument holder.
 8. The self-retaining retractor of claim 1wherein the rotatable connection between the medial arm and theextension arm further comprises a lockable connection.
 9. Theself-retaining retractor of claim 8 wherein the lockable connectioncomprises: a gap in the rotatable connection for insertion of a lockingpin; and the locking pin.
 10. The self-retaining retractor of claim 1wherein the connection between the extension arm and the lateral arm isremovable.
 11. The self retaining retractor of claim 10, wherein theconnection between the extension arm and the lateral arm may be madeafter the medial arm is deployed.
 12. The self-retaining retractor ofclaim 11 wherein the connection between the extension arm and thelateral arm is a pin-and-slot joint.
 13. The self-retaining retractor ofclaim 1, further comprising: a first band connector located on the firstend of the medial arm; and a second band connector located on the firstend of the lateral arm.
 14. The self-retaining retractor of claim 1,further comprising: a band in a tightenable connection with the firstend of the medial arm and the first end of the lateral arm.
 15. Amedical device, comprising: a body element selectively transitionablefrom a first geometric configuration to a second geometricconfiguration, the body element having a medial arm having a first endand a second end, wherein the second end is a curved Hohmann retractorend; a lateral arm having a first end and a second end; and an extensionarm in lockable, hinged connection to the medial arm, capable of hingedconnection with the second end of the lateral arm, wherein extension ofthe extension arm transitions the body element from a first geometricconfiguration to a second geometric configuration.
 16. The medicaldevice of claim 15, further comprising at least one holder for asurgical instrument located on at least one of: the medial arm and thelateral arm.
 17. The medical device of claim 15, wherein the connectionwith the lateral arm is removable.
 18. The medical device of claim 17,wherein the connection with the lateral arm may be made after the medialarm is deployed.
 19. The medical device of claim 18, further comprising:a first tightening element connector located on the first end of themedial arm; and a second tightening element connector located on thefirst end of the lateral arm.
 20. A method of retracting tissuecomprising the steps of: having a medical device, wherein the medicaldevice comprises a medial arm having a near end and a far end, whereinthe far end comprises a curve; and an extension arm having a near endand a far end, wherein the near end of the extension arm in hingedconnection in proximity to the far end of the medial arm, the extensionarm being capable of being in an undeployed position or deployedposition; introducing the medical device into an incision with theextension arm in the undeployed position; placing the curve under a boneaccessible through the incision; and extending the extension arm into anextended position.
 21. The method of claim 20, wherein a lateral armhaving a near end and a far end is attached at the far end of thelateral arm to the far end of the extension arm.
 22. The method of claim21, wherein the lateral arm is attached at the far end to the far end ofthe extension arm before the extension arm is extended into the extendedposition.
 23. The method of claim 21, wherein the lateral arm isattached at the far end to the far end of the extension arm after themedical device is introduced into the incision.
 24. The method of claim20, further comprising the step of locking the extension arm in theextended position.
 25. The method of claim 20, wherein the medicaldevice further comprises a tightening element in connection with thenear end of the medial arm and the near end of a lateral arm, furthercomprising the step of tightening a tightening element.